Impact of Treatment With Targeted Therapies on the Generation of CAR T Cells in CLL Patients

  • STATUS
    Recruiting
  • End date
    Oct 21, 2024
  • participants needed
    23
  • sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto
Updated on 21 March 2022
venetoclax
ibrutinib

Summary

In this biological study, blood samples will be collected from patients with CLL treated with targeted agents (ibrutinib and venetoclax) to assess the impact of these treatments on the generation of CAR T cells in terms of manufacturing efficiency, immunophenotypic characteristics and functional properties.

Description

This is a biological study aimed at analyzing the features of CAR T cells generated in CLL patients treated with ibrutinib or venetoclax.

To this purpose, blood samples will be collected from patients with CLL before starting therapy with ibrutinib or venetoclax and after 6 and 12 months of treatment.

Anti-CD19 CAR T cells will be generated and tested for: (i) viability, expansion and generation efficiency; (ii) phenotypic characteristics, in terms of CD4/CD8 composition, differentiation subset distribution, exhaustion markers and expression of immune checkpoint molecules; (iii) in vitro functional properties, in terms of proliferation ability, cytokines production, cytotoxic activity and killing of target cells. CAR T cells produced from the same patient at different timepoints will be compared. Phenotypic and functional data on CAR T cells will be also correlated with main CLL prognostic factors (e.g. IGHV mutational status, FISH abnormalities, TP53 mutation status) and outcome variables (response status, duration of response).

Details
Condition CLL, Chronic Lymphocytic Leukemia
Treatment Peripheral blood samples withdrawal
Clinical Study IdentifierNCT04640909
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of CLL/SLL meeting the IWCLL 2008 criteria
≥18 years old
Indication for treatment with targeted therapies (i.e. ibrutinib or venetoclax)
Anticipated possibility to collect blood samples at the baseline and at 6- and 12-month timepoints
Signed written informed consent according to ICH/EU/GCP and national local laws
Confirmed availability of the laboratory to enroll and to process patient samples

Exclusion Criteria

Expected treatment duration with targeted drug < 12 months, according to treating physician
Previously treated with more than 2 lines of CLL-directed therapy
Concurrent use of systemic steroids or chronic use of immunosuppressive medications
Active HBV (HBsAg+ or HBV DNA+) or HCV or HIV infection
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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